The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for Catheters, H-h Atrial And Peritoneal.
| Device ID | K781768 |
| 510k Number | K781768 |
| Device Name: | CATHETERS, H-H ATRIAL AND PERITONEAL |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | HOLTER-HAUSNER INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-16 |
| Decision Date | 1978-11-14 |